Puma Leaps After Hours, FDA Delays Decision On Merck's Drug, ADMP Optimistic

(RTTNews) - Allergan plc's (AGN) wholly owned subsidiary, Watson Laboratories Inc. has decided to terminate the license agreement with Adamis Pharmaceuticals Corp. (ADMP) for Epinephrine Pre-filled Syringe.

Adamis' Epinephrine Pre-filled Syringe is a product candidate for the emergency treatment of anaphylaxis in the United States.

Anaphylaxis is a serious, sometimes life-threatening allergic reaction. The most common anaphylactic reactions are to foods, insect stings, medications and latex.

Epinephrine Pre-filled Syringe (PFS) was issued a Complete Response Letter by the FDA twice - in June of this year and March 2015.

Commenting on the development, Dennis Carlo, President and CEO of Adamis, stated, "I believe that today our PFS represents a greater opportunity for the Company than it did when we entered into the agreement with Watson. Although Watson has chosen to terminate the license agreement, I view this as a good opportunity to further explore the wide range of strategic options that we believe currently exist in this ever improving market. While one might initially consider this to be a disappointment, it could very well end up being a positive development for the Company".

The company plans to meet with the FDA this quarter and is expected to resubmit its updated NDA for Epinephrine Pre-filled Syringe by the end of this year.

ADMP closed Thursday's trading at $3.03, up 0.66%.

Gilead Sciences Inc.'s (GILD) two phase 3b studies exploring the efficacy and safety of Odefsey among virologically suppressed adult patients switching from Complera or Atripla met their primary objectives.

Odefsey, the smallest single tablet HIV regimen of Gilead received FDA approval in March of this year as a complete regimen for the treatment of HIV-1 infection in patients 12 years of age and older who have no antiretroviral treatment history and HIV-1 RNA levels =100,000 copies/mL.

According to the study results, at Week 48, the virologic suppression was maintained in 94 percent of patients taking Odefsey and in 94 percent of patients taking Complera in Study 1216, and in 90 percent of patients taking Odefsey versus 92 percent of patients taking Atripla in Study 1160.

The results from the two studies support the efficacy, as well as the renal and bone safety profile of Odefsey as a new treatment option for virologically suppressed patients, says the company.

GILD closed Thursday's trading at $87.24, up 0.67%.

The FDA decision on Merck's (MRK) Biologics Licensing Application for Bezlotoxumab, an investigational agent for prevention of Clostridium difficile infection recurrence, which was scheduled for July 23, 2016, is going to be delayed by 3 months as the company has been asked to submit new data.

The regulatory agency's final decision is now slated for October 23, 2016.

On June 9, 2016, an FDA panel voted 10-to-5, with one abstention, in support of Bezlotoxumab as showing substantial evidence of efficacy and safety in preventing the recurrence of C. difficile infection.

MRK closed Thursday's trading at $58.79, unchanged from the previous day's close.

Shares of Puma Biotechnology Inc. (PBYI) were up over 20% in extended trading on Thursday, following encouraging interim 5-year invasive disease free survival results from the company's phase III trial of PB272 (Neratinib) in extended adjuvant HER2-positive early stage breast cancer.

The top line results from the study, dubbed ExteNET, were first reported in July 2014.

According to the 5-year interim results of the trial, treatment with Neratinib resulted in a 26% reduction of risk of invasive disease recurrence or death versus placebo. The 5-year interim invasive DFS (disease free survival) rate for the Neratinib arm was 90.4% and the 5-year interim invasive DFS rate for the placebo arm was 87.9%.

The company has submitted the New Drug Application for PB272 (Neratinib) to the FDA.

PBYI closed Thursday's trading at $34.52, up 4.38%. In after hours, the stock was up 20.19% to $41.49.

Shares of Relypsa Inc. (RLYP) were up over 58% on Thursday, on news of the company's acquisition by Switzerland-based Galenica Group for $32 per share in cash, or a total of approximately $1.53 billion.

Galencia Group is expected to be split into two independent listed companies? namely, Vifor Pharma and Galenica Sante, in 2017.?

The acquisition of Relypsa is expected to significantly strengthen Vifor Pharma ahead of the planned division, with an extensive specialist product portfolio to include both the intravenous iron deficiency treatment Ferinject and Veltassa.

RLYP closed Thursday's trading at $31.95, up 58.96%.